Trial Outcomes & Findings for Zoledronic Acid and Positron Emission Tomography in Treating Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT00559897)

NCT ID: NCT00559897

Last Updated: 2015-02-04

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

FLT PET scan will be done 6-8 days after the dose of zoledronic acid

Results posted on

2015-02-04

Participant Flow

Participant milestones

Participant milestones
Measure
3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid
Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-\[18F\]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid. 3'-deoxy-3'-\[18F\]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid. Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
Overall Study
STARTED
6
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Zoledronic Acid and Positron Emission Tomography in Treating Patients With Advanced Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid
n=6 Participants
Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-\[18F\]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid. 3'-deoxy-3'-\[18F\]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid. Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
Region of Enrollment
United States
6 participants
n=5 Participants

PRIMARY outcome

Timeframe: FLT PET scan will be done 6-8 days after the dose of zoledronic acid

Outcome measures

Outcome data not reported

Adverse Events

3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid
n=6 participants at risk
Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-\[18F\]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid. 3'-deoxy-3'-\[18F\]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid. Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
Psychiatric disorders
Altered Mental Status
16.7%
1/6 • Number of events 1 • At week 3

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shirish Gadgeel

Barbara Ann Karmanos Cancer Institute

Phone: 313-576-8753

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place